Safety and Immunogenicity Study of Candidate HIV-1 Vaccin... | NCT00982579

Studies
Safety and Immunogenicity Study of Candidate HIV-1 Vaccine Given to Healthy Infants Born to HIV-1/2-uninfected Mothers

NCT00982579

Sponsor

Medical Research Council

Status

Completed

Last Update Posted

Feb 3, 2012Estimated

Enrollment

48Actual

Phase

Phase 1

Conditions

HIV-1
HIV Infections

Interventions

MVA.HIVA

Countries

The Gambia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Jun 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Sep 22, 2009

First Submission Date that Met QC Criteria

Sep 22, 2009

First Posted Date

Sep 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2012

Last Update Posted Date

Feb 3, 2012Estimated

Name	Class
European and Developing Countries Clinical Trials Partnership (EDCTP)	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Objectives:

Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Gambian infants born to HIV-1/2-uninfected mothers.

Gross impact of MVA.HIVA on the immunogenicity of EPI vaccines (DTwPHib, HepB, PCV-7 and OPV) when administered at 20 weeks (4 weeks after the last EPI vaccines), who have had BCG vaccine within the first 4 weeks of life.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vaccinees	Experimental	Vaccinated at 20 weeks of age (n=24)	Biological: MVA.HIVA
Controls	No Intervention	No experimental vaccine (n=24)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MVA.HIVA	Biological	1 dose of 5 x 10^7 pfu of MVA.HIVA administered intramuscularly	Vaccinees

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
For safety and reactogenicity: Actively and passively collected data on adverse events		Up to 16 weeks after vaccination

Secondary Outcomes

Measure	Description	Time Frame
For immunity to EPI vaccines: Antibody levels to specific vaccines.		1 week before and 1 week after vaccination
For immunogenicity: Frequency of IFN-γ producing cells determined in ex-vivo (effector) and 10-day cultured (memory) ELISPOT assays after overnight stimulation with pools of HIVA-derived peptides

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy infants, 19 weeks of age, with weight for age z-scores within 2 standard deviations of normal.
Have received all standard EPI immunizations according to national immunization programme.
Written informed consent by parent.
Mother HIV-1/2-uninfected.

Exclusion Criteria:

Acute disease at the time of vaccination (acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory tract infection with or without low-grade febrile illness, i.e. axillary temperature of <37.5 °C ).
Axillary temperature of ≥ 37.5 °C at the time of vaccination.
Any clinically significant abnormal finding on screening from biochemistry or haematology at 19 weeks.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products.
Presence of any underlying disease that compromises the diagnosis and evaluation of response to the vaccine.
Invasive bacterial infections (pneumonia, meningitis).
Any other on-going chronic illness requiring hospital specialist supervision.
Administration of immunoglobulins and/or any blood products within one month preceding the planned administration of the vaccine candidate.
Any history of anaphylaxis in reaction to vaccination.
Research physician's assessment of lack of willingness by parents to participate and comply with all requirements of the protocol, or identification of any factor felt to significantly increase the infant's risk of suffering an adverse outcome.
Likelihood of travel away from the study area.
Untreated malaria infection.
Any other clinical evidence of infection.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

3 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Tomas Hanke	Medical Research Council	Study Director
Katie Flanagan	Medical Research Council, The Gambia	Principal Investigator
Marie Reilly	Karolinska Institutet	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Medical Research Council Laboratories, The Gambia		Banjul	Fajara		The Gambia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24205185	Derived	Afolabi MO, Ndure J, Drammeh A, Darboe F, Mehedi SR, Rowland-Jones SL, Borthwick N, Black A, Ambler G, John-Stewart GC, Reilly M, Hanke T, Flanagan KL. A phase I randomized clinical trial of candidate human immunodeficiency virus type 1 vaccine MVA.HIVA administered to Gambian infants. PLoS One. 2013 Oct 24;8(10):e78289. doi: 10.1371/journal.pone.0078289. eCollection 2013.

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral